NCT06444022

hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation

Clinical Study of hAESCs on Prevention of Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a parallel controlled clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.

Detailed description

This study is a controlled trial, with 18 subjects enrolled in the experimental group or the control group. The study will consist of four phases, including screening phase, preparation phase, hAESCs treatment phase and observational follow-up period. The cell dose of the experimental group was 1x10\^6 cells/kg and the control group is infused placebo (the composition was the same as hAESCs injection excipients, but did not contain hAESCs). The infusion of hAESCs/placebo at the day before HSCT and 7th days after HSCT.

Conditions

• Acute Graft Versus Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	Human amniotic epithelial stem cells（hAESCs）	Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation (hAECs-GVHD)
BIOLOGICAL	placebo (cell preservation solution)	Same dose placebo (cell preservation solution) injections as control group

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2024-06-05
• Last updated: 2026-04-16